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Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.

RecruitingPhase 1Ages 18 Years - 65 YearsAllUniversity of Alabama at Birmingham
NCT03759522 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

The primary objective of this study is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET radiopharmaceutical \[F-18\]DPA-714 in individuals with chronic pain and fatigue suspected to be associated with neuroinflammation. The PET tracer \[F-18\]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The primary objective of this study is to determine if pain and fatigue patients have higher levels of neuroinflammation than HC individuals as measured with \[F-18\]DPA-714-PET/MRI.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. 18 to 65 years of age 2. Healthy volunteer OR Clinical diagnosis of Multiple Sclerosis (MS) OR Meets 2016 American College of Rheumatology (ACR) case definition criteria for fibromyalgia OR Meets 1994 Fukuda case definition criteria for Chronic Fatigue Syndrome Exclusion Criteria: 1. Contraindication to MRI 2. Pregnancy 3. Lactation 4. Individuals who are unable to participate in the imaging portion due to severity of their medical condition 5. Chronic infectious disease (e.g. HIV, HCV) 6. Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation 7. Diagnosis of cancer, including leukemia 8. Blood or blood clotting disorder 9. Except for individuals with MS, a diagnosis of autoimmune disease is exclusionary 10. Positive urine ฮฒ-hCG test day of procedure or a serum -hCG test within 48 hours prior to the administration of \[18F\]DPA-714 11. Currently enrolled in a clinical trial utilizing experimental therapies
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What it tests

  • DPA-714 PET/MRI
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Where

1 site
University of Alabama at Birmingham Medical Center
Birmingham, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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